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500 "Normal" Adult Subjects Who Have Experienced no Known Brain Injury Will Participate in Collecting Data That Will Assist With the Optimization of the Diagnostic Capabilities of the Harmony in Detecting Neurologic Abnormalities.

NCT05203393 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-11-16

No results posted yet for this study

Summary

The REFRESH study is designed to collect data related to a signal in the brain that MindRhythm has named the Headpulse. The Headpulse occurs as a natural movement of the brain in conjunction with the beating of the heart. 500 "normal" subjects who are considered healthy as they do not have any current known neurological injury will collect the brain signal data from the non-invasive headband style headset for a duration of 3 minutes either once or multiple times. Upon consenting to participate to the study by way of the accompanying MindRhythm app, participants will be sent a Harmony headset kit which will include ECG leads to collect cardiac data in conjunction with the brain signal. The participant will receive training materials and instructions on how to collect and transmit data to investigators by way of the MindRhythm app. The data collected by these "normal" patients will be used as a comparator to individuals who are suspected of neurological injury. This data will assist in training the data analysis algorithm to optimize its diagnostic abilities in detecting neurological injury or abnormalities including but not limited to stroke, stroke type, and concussion. The data set will also be analyzed to determine how the signal varies within an individual and amongst other "normals." An additional benefit of collecting this data will be to gain knowledge related to the ergonomic factors of the app and the headset and its "user friendliness."

Conditions

  • Cranial Waveform in Normal Patients as a Result of Cardiac Cycle
  • Healthy

Interventions

DEVICE

Harmony Headset

The Harmony headset is a non-invasive nonsignificant risk observational device to collect intracranial waveform data. The headset will be placed on "normal" study participants to collect data for a period of 3 minutes and transferred to investigators for analysis.

Sponsors & Collaborators

  • MindRhythm, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Lovoi, PhD · Chief Technical Officer, MindRhythm Incorporated

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2023-01-15
Completion
2023-01-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203393 on ClinicalTrials.gov